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Enrolling by invitation NCT07576933

Effects of Two Intervention Programs on Physical Fitness and Quality of Life Among People With Intellectual Disabilities

No phase Interventional Intellectual Disabilities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Traditional physical conditioning, Sport-based individual skills.
Who it may be relevant to
Registry conditions: Intellectual Disabilities. Basic parameters: 19 years — 37 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Intellectual Disability (ID) is characterized by limitations in cognitive functioning and adaptive behavior, often leading to a sedentary lifestyle and lower quality of life. The main objective of this study is to compare the efficacy of two different 8-week training programs on physical fitness and quality of life in adults with ID. The work methodology consists of a randomized controlled trial with two intervention groups: Experimental Group 1 (EG1): Traditional conditioning including strength and resistance exercises (medicine ball, rowing, and coordination circuits). Experimental Group 2 (EG2): Sport-based individual skills program (Special Olympics model) covering soccer, basketball, athletics, and other sports with a playful approach. The sample will be composed of sedentary adults with a clinical diagnosis of ID. The variables studied pre- and post-intervention include body composition, physical fitness (agility, strength, and cardiorespiratory capacity), blood pressure, and quality of life using the INICO-FEAPS scale.

Detailed description

Intellectual Disability (ID) is characterized by limitations in intellectual functioning and adaptive behavior, affecting conceptual, social, and practical skills. Beyond Intelligence Quotient (IQ), ID impact depends on various factors of functioning and adaptive skills. According to the International Classification of Functioning (ICF), individuals with ID often experience difficulties in communication, self-care, decision-making, and problem-solving, as well as impaired psychomotor functioning and mobility. Consequently, this population often reports lower quality of life and reduced participation in social and recreational activities.

While physical activity is fundamental for cognitive, emotional, and physical well-being, individuals with ID have significantly lower rates of exercise practice, which is linked to increased health problems such as obesity and cardiovascular diseases. The main objective of this study is to analyze and compare the efficacy of two different training programs on physical fitness and quality of life in sedentary adults with ID.

Working Methodology The study is a randomized controlled trial (RCT) conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the Catholic University of Murcia (UCAM). The intervention will last 8 weeks, with 2 sessions per week (16 total sessions), each lasting 60 minutes.

The intervention groups are:

Experimental Group 1 (EG1): Traditional conditioning program based on analytical exercises. Sessions include a 5-minute joint mobility warm-up, a 45-minute main phase with constant exercises (medicine ball squats, thrusters, band rowing, chest press, and coordination circuits), and a 5-minute cool-down. Intensity is moderate and progressed linearly by increasing exercise duration from 60 to 90 seconds.

Experimental Group 2 (EG2): Sport-based individual skills program (Special Olympics model). Sessions include activities from soccer, basketball, floorball, athletics, and boccia. Each sport block (3 sessions each) focuses on technical progression (aiming, dribbling, shooting) with a playful approach and real-game situations.

The assessment and protocols are:

Pre- and post-intervention measurements include:

Physical Fitness (SAMU-DISFIT Battery): Evaluation of agility (Timed Up and Go), flexibility (Sit and Reach), manual strength (handgrip dynamometry), abdominal resistance (30-sec sit-ups), lower limb functionality (10-repetition squat test), and cardiorespiratory capacity (6-Minute Walk Test).

Body Composition: Body Mass Index (BMI) and waist circumference (CC) measured following standard protocols, along with bioimpedance analysis for fat mass and muscle percentage.

Strength and Hemodynamics: Lower limb explosive strength via Vertical Jump (CMJ) using Chronojump, and blood pressure measured after a 5-minute rest.

Quality of Life: Comprehensive assessment using the INICO-FEAPS Scale, evaluating 8 multidimensional domains through self-report.

Interventions

  • Behavioral Traditional physical conditioning
    The traditional multi-component training group will perform 60 minutes of training per session, 2 days a week for 8 weeks. The program includes: A 5-minute warm-up, which includes joint mobility exercises led by the instructor. A 45-minute main phase, which includes targeted endurance and strength training using a circuit-based approach. Exercises include medicine ball squats, medicine ball thrusters, seated resistance band rows, and chest presses. The circuit is completed once, and the durati
  • Behavioral Sport-based individual skills
    The sports skills group will conduct 60-minute training sessions twice a week for 8 weeks, following the Special Olympics Individual Skills model. The sessions follow the same structure. A 5- to 10-minute warm-up consisting of a fun, sport-related game designed to increase heart rate and motivation. The main part lasts 45 minutes, during which different skills for each sport are practiced, such as shooting, passing, dribbling, and coordination. The sports covered are soccer, basketball, floorb

Primary outcome measures

  • Changes in Time Up and Go from baseline at week 8 [Time frame: Two times. Baseline and 8 weeks later.]
Secondary outcome measures (12)
  • Changes in Sit and Reach from baseline at week 8 [Time frame: Two times. Baseline and 8 weeks later]
  • Changes in Hand Grip from baseline at week 8 [Time frame: Two times. Baseline and 8 weeks later]
  • Changes in Sit-ups in 30 seconds from baseline at week 8 [Time frame: Two times. Baseline and 8 weeks later]
  • Changes in 6-minute walk from baseline at week 8 [Time frame: Two times. Baseline and 8 weeks later]
  • Changes in 10 squats from baseline at week 8 [Time frame: Two times. Baseline and 8 weeks later]
  • Changes in CMJ from baseline at week 8 [Time frame: Two times. Baseline and 12 weeks later]
  • Changes in Blood Pressure from baseline at week 8. [Time frame: Two times. Baseline and 8 weeks later]
  • Changes in Height from baseline at week 12. [Time frame: Two times. Baseline and 8 weeks later]
  • Changes in Waist circumference from baseline at week 8 [Time frame: Two times. Baseline and 8 weeks later]
  • Changes in Body Fat Percentage from baseline at week 8 [Time frame: Two times. Baseline and 8 weeks later]
  • Changes in weight from baseline at 8 weeks. [Time frame: Two times. Baseline and 8 weeks later]
  • Changes in Body Mass Index from baseline at week 8 [Time frame: Two times. Baseline and 8 weeks late]

Eligibility criteria

Inclusion criteria

  • Have a clinically diagnosed intellectual disability
  • Have not engaged in 150 minutes of physical activity per week over the past six months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • UCAM — Murcia

Identifiers

NCT: NCT07576933 · UCMurcia-

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗